An observational study in Patients With Severe Chronic Pain, sponsored by Jazz Pharmaceuticals. Completed at 43 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-16.
Sponsored by Jazz Pharmaceuticals · Observational
The objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (HRQoL) associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 93 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Up to 140 patients will be enrolled at approximatley 50 sites in the United States.
Exclusion Criteria:
Drug: Ziconotide
The effectiveness of PRIALT therapy for the management of severe chronic pain as evidenced by change in patient-reported pain intensity from baseline to 12 weeks after enrollment
Time frame: 12 Weeks
Evaluate the following from the patient's perspective via patient reported outcomes (PROs)
Time frame: From week 12, every 3 months up to month 18
Evaluate the patient's global impression of change (PGIC) with PRIALT treatment
Time frame: From week 12, every 3 months up to month 18
Evaluate changes in concomitant pain medication use
Time frame: From week 12, every 3 months up to month 18
Evaluate long-term safety and tolerability data, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From week 12, every 3 months up to month 18
The use of PRIALT in current clinical practice including dose at initiation, titration speed, effective dose, duration of treatment effect, use of other pain medications, etc.
Time frame: From week 12, every 3 months up to month 18
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Jazz Pharmaceuticals